Filter system and method

ABSTRACT

A filter system, comprising an elongate filter body defining a lumen and having a proximal end and a distal end. A valve can be provided defining a lumen and having a reversibly sealable opening for unidirectional flow of a fluid through the lumen. The valve can be adjoined proximal the distal end of the elongate filter body, wherein the elongate filter body filters the unidirectional flow of the fluid passing through the lumen of the valve and the lumen of the elongate filter body.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/604,125, filed Jan. 23, 2015, which is a continuation of U.S.application Ser. No. 11/049,019, filed Feb. 1, 2005.

FIELD OF THE INVENTION

The present invention relates generally to apparatus, systems, andmethods for use in a lumen; and more particularly to a valve and filterapparatus, system, and method for use in the vasculature system.

BACKGROUND OF THE INVENTION

Cardiac valves can become damaged and/or diseased for a variety ofreasons. Damaged and/or diseased cardiac valves are grouped according towhich valve or valves are involved, and the amount of blood flow that isdisrupted by the damaged and/or diseased valve. The most common cardiacvalve diseases occur in the mitral and aortic valves. Diseases of thetricuspid and pulmonary valves are fairly rare.

The aortic valve regulates the blood flow from the heart's leftventricle into the aorta. The aorta is the main artery that suppliesoxygenated blood to the body. As a result, diseases of the aortic valvecan have a significant impact on an individual's health. Examples ofsuch diseases include aortic regurgitation and aortic stenosis.

Aortic regurgitation is also called aortic insufficiency or aorticincompetence. It is a condition in which blood flows backward from awidened or weakened aortic valve into the left ventricle of the heart.In its most serious form, aortic regurgitation is caused by an infectionthat leaves holes in the valve leaflets. Symptoms of aorticregurgitation may not appear for years. When symptoms do appear, it isbecause the left ventricle must work harder relative to an uncompromisedaortic valve to make up for the backflow of blood. The ventricleeventually gets larger and fluid backs up.

Aortic stenosis is a narrowing or blockage of the aortic valve. Aorticstenosis occurs when the valve leaflets of the aorta become coated withdeposits. The deposits change the shape of the leaflets and reduce bloodflow through the valve. Again, the left ventricle has to work harderrelative to an uncompromised aortic valve to make up for the reducedblood flow. Over time, the extra work can weaken the heart muscle.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1B illustrate an embodiment of a filter system.

FIGS. 2A-2B illustrate another embodiment of a filter system.

FIGS. 3A-3C illustrate another embodiment of the filter system.

FIGS. 4A-4D illustrate another embodiment of the filter system.

DETAILED DESCRIPTION

Embodiments of the present invention are directed to a filter system andmethod for temporary placement and use in a lumen. Embodiments of thepresent invention are also directed to augmenting cardiac valve functionwhile filtering fluid moving within the lumen. For example, the filtersystem and method can be used to temporarily replace, or augment, anincompetent valve in a body lumen and/or can be used as a temporaryvalve during a procedure to repair or to replace an incompetent valvewith a prosthetic valve.

Embodiments of the filter system can further include a sheath that canbe used to help position the filter system within a body lumen, such asan artery or a vein, through minimally-invasive techniques. In furtherembodiments, additional structures can be used in conjunction with thefilter system. For example, catheters having tissue shearing capability,stent delivery capability, and prosthetic valve delivery capability canalso be used in conjunction with the filter system to aid in thereplacement of a diseased native valve with a prosthetic valve. In anadditional embodiment, the sheath can include a deployment rod to extendand retract the cardiac valve and filter. After replacement or repair ofa native valve, the filter system can be retracted into the lumen of thesheath.

The Figures herein follow a numbering convention in which the firstdigit or digits correspond to the drawing Figure number and theremaining digits identify an element or component in the drawing.Similar elements or components between different Figures may beidentified by the use of similar digits. For example, 110 may referenceelement “10” in FIG. 1, and a similar element may be referenced as 210in FIG. 2. As will be appreciated, elements shown in the variousembodiments herein can be added, exchanged, and/or eliminated so as toprovide any number of additional embodiments of the filter system. Inaddition, the elements shown in the various embodiments are notnecessarily to scale.

Various embodiments of the invention are illustrated in the figures.Generally, the filter system can be used to provide a temporary valvefor replacement or repair of a diseased and/or damaged valve. Otherembodiments can be used to provide a temporary valve and filter during aprocedure to repair a diseased or damaged valve or replace a diseasedand/or damaged valve with a permanent valve. For example, the placementof the valve and filter apparatus within a body lumen (e.g., within theaorta, adjacent the aortic valve), can help to provide for a temporaryvalve and filter to regulate fluid flow and filter particulate matterfrom fluid flowing through the aorta during transluminal cardiac valverepair and/or replacement.

FIGS. 1A and 1B illustrate one embodiment of a filter system 100 shownin perspective view. Filter system 100 includes an elongate filter body102 including an expandable filter region 150 and a valve 104. FIGS. 1Aand 1B provide a perspective illustration of the valve 104 of filtersystem 100 in an open configuration (FIG. 1A) and a closed configuration(FIG. 1B). In addition, the perspectives illustrated in FIGS. 1A and 1Bshow the filter system 100 in an expanded configuration, as will bediscussed herein.

In the present embodiments, the elongate filter body 102 defines a lumen106 extending from a proximal end 108 towards a distal end 110. In oneembodiment, the lumen 106 can be concentric with an elongate axis of theelongate filter body 102. The valve 104 also defines a lumen 112. In oneexample, the valve 104 can be adjoined proximal the distal end 110 ofthe elongate filter body, where the lumen 112 of the valve 104 and thelumen 106 of the elongate filter body 102 can form a single lumen 114.In other words, the lumens 106 and 112 can be contiguous so as to formthe single lumen 114. Other configurations are also possible.

In the various embodiments, filter system 100 allows for bothunidirectional flow of fluid and filtering of the fluid passing throughthe lumens 106 and 112. With respect to providing unidirectional flow ofthe fluid through lumens 106 and 112, the valve 104 includes areversibly sealable opening 116. In one embodiment, the reversiblysealable opening 116 can be formed by one or more valve leaflets 118. Informing the reversibly sealable opening 116, the valve leaflets 118 areconfigured to move between an open configuration (e.g., FIG. 1A,allowing fluid to flow in a first direction 193 through the lumens 106and 112) and a closed configuration (e.g., FIG. 1B, preventing fluidfrom flowing in a second direction 197 opposite the first direction193).

The valve 104 can include any number of configurations so as to definethe lumen 112 and provide the reversibly sealable opening 116 forunidirectional flow of the fluid through the lumen 112. For example, thevalve 104 can include a frame 120 that supports a cover 122. In thevarious embodiments, the cover 122 defines the reversibly sealable valveleaflets 118 that provide for the unidirectional flow of a fluid throughthe lumen 112 of the valve 104.

Examples of a valve suitable for use as valve 104 is illustrated in U.S.patent application Ser. No. 10/741,995, entitled “Venous ValveApparatus, System, and Method”, and in U.S. patent application Ser. No.11/052,655, entitled “Venous Valve Apparatus, System, and Method”, bothof which are hereby incorporated by reference in their entirety. Asillustrated, frame 120 includes a variety of structural configurations.Generally, the frame 120 has a curved structural configuration, as willbe discussed herein. For example, the frame 120 can include a firstelliptical member 124 and a second elliptical member 126, as illustratedin FIGS. 1A and 1B.

In the various embodiments, the first elliptical member 124 and thesecond elliptical member 126 meet at a first region 128 and a secondregion 130, where the first region 128 and the second region 130 areopposite each other across axis 132. The first region 128 and the secondregion 130 can be located at any number of locations along the firstelliptical member 124 and the second elliptical member 126. For example,the first region 128 and the second region 130 can be at or near a minoraxis of the first elliptical member 124 and the second elliptical member126. In an additional embodiment, the first region 128 and the secondregion 130 can be positioned away from the minor axis of the firstelliptical member 124 and the second elliptical member 126.

While the term elliptical member is used herein, other shapes arepossible for the structural members that help to form a valve accordingto the embodiments herein. For example, the frame 120 can includecircular members that meet at the first region 128 and the second region130. Other shapes besides elliptical and circular are also possible.

The first elliptical member 124 and the second elliptical member 126meet at the first region 128 and the second region 130 at an angle 134.In one embodiment, the size of angle 134 when the valve 104 is expandedcan be selected based upon the type of body lumen and the body lumensize in which the valve 104 is to be placed. Additional factors include,but are not limited to, a longitudinal length 136 and a width 138 of thevalve 104. These factors, along with others discussed herein, can beused to provide the angle 134 that is sufficient to ensure that thefirst elliptical member 124 and the second elliptical member 126 have anappropriate expansion force against an inner wall of the body lumen inwhich the valve 104 is being placed.

The valve 104 also includes a flexible joint at and/or around axis 132that allows the valve 104 to accommodate changes in body lumen size(e.g., diameter of the body lumen) by increasing or decreasing angle 134when the valve 104 is expanded. In addition, the frame 120 also has theability to flex, as discussed herein, to allow for the distance betweenthe first region 128 and the second region 130 to increase or decrease,thereby further accommodating changes in the body lumen size (e.g.,diameter of the body lumen). The frame 120 also provides sufficientcontact and expansion force with the surface of a body lumen wall toencourage seating of the valve 104 and to prevent retrograde flow, i.e.,second direction 197, within the body lumen.

The frame 120 can be formed from a biocompatible metal, metal alloy,polymeric material, or combinations thereof, which allow the frame 120to move radially between the collapsed and expanded state, as discussedherein. To accomplish this, the biocompatible metal, metal alloy, orpolymeric material should exhibit a low elastic modulus and a high yieldstress for large elastic strains that can recover from elasticdeformations. Examples of suitable materials include, but are notlimited to, medical grade stainless steel (e.g., 316L), titanium,tantalum, platinum alloys, niobium alloys, cobalt alloys, alginate, orcombinations thereof. In an additional embodiment, the frame 120 may beformed from a shape-memory material. Examples of a suitable shape-memorymaterial include, but are not limited to, alloys of nickel and titaniumin specific proportions known in the art as nitinol. Other materials arealso possible.

The valve 104 can further include one or more radiopaque markers 152(e.g., tabs, sleeves, welds). For example, one or more portions of theframe 120 can be formed from a radiopaque material. Radiopaque markerscan be attached to and/or coated onto one or more locations along theframe 120. Examples of radiopaque materials include, but are not limitedto, gold, tantalum, and platinum. The position of the one or moreradiopaque markers can be selected so as to provide information on theposition, location and orientation of the valve 104 during itsimplantation.

The valve 104 further includes the cover 122. In the variousembodiments, the cover 122 forms the valve leaflets 118 joined to valveframe 120. The valve leaflets 118 can deflect between a closedconfiguration (FIG. 1B) in which retrograde fluid flow through the valve104 is restricted, and an open configuration (FIG. 1A) in whichantegrade fluid flow through the valve 104 is permitted. In oneembodiment, valve leaflets 118 of the valve are configured to open andclose in response to the fluid motion and/or pressure differentialacross the valve leaflets 118.

The example of valve 104 shown in FIGS. 1A and 1B provide embodiments inwhich the surfaces defining the reversibly sealable opening 116 includea first leaflet 140 and a second leaflet 142 coupled to the valve frame120 to provide a two-leaflet configuration (i.e., a bicuspid valve) forvalve 104. Although the embodiments illustrated in FIGS. 1A-1B of thepresent invention show and describe a two-leaflet configuration forvalve 104, designs employing a different number of valve leaflets (e.g.,tricuspid valve) are possible and considered within the scope of theembodiments.

The valve leaflets 118 can have a variety of sizes and shapes. Forexample, each of the valve leaflets 118 (e.g., first leaflet 140 andsecond leaflet 142) can have a similar size and shape. In an additionalexample, each of the valve leaflets 118 need not have valve leaflets 118that are of a similar size and shape (i.e., the valve leaflets can havea different size and shape).

Valve frame 120 can include an open frame construction (i.e., valveframe 120 defines an opening) through which valve leaflets 118 canradially-collapse and radially-expand. The valve leaflets 118 can beprovided over the open frame construction of the valve frame 120 todirect fluid flow through reversibly sealable opening 116 under specificfluid flow conditions. In one embodiment, the material of the valveleaflets 118 coupled to the valve frame 120 can be sufficiently thin andpliable so as to permit radially-collapsing of the valve leaflets 118for delivery by catheter to a location within a body lumen.

In one embodiment, each of the valve leaflets 118 includes sufficientexcess material spanning valve frame 120 such that fluid pressure (e.g.,antegrade flow) acting on the valve leaflets 118 forces the valve 104into an open configuration (FIG. 1A). Valve leaflets 118 can furtherinclude arcuate edges 144 and 146, as shown in FIG. 1A, that arepositioned adjacent each other along a substantially catenary curvebetween the first region 128 and the second region 130 in the closedconfiguration (FIG. 1B) of valve 104. Similarly, arcuate edges 144 and146 can help to define lumen 112 when the valve 104 is in the openconfiguration (FIG. 1A).

In an additional embodiment, in the open configuration the sufficientexcess material spanning the valve frame 120 can allow the valveleaflets 118 to take on a semi-tubular structure, as shown in FIG. 1A,when fluid pressure opens the valve 104. In an additional embodiment,arcuate edge 144 and 146 of valve 100 can open to approximately the fullinner diameter of body lumen.

Each of the valve leaflets 118 can further include a curve impartedthereto so as to provide a concave structure 148 to the leaflet 118. Theconcave structure 148 allows the valve leaflets 118 to better collectretrograde fluid flow to urge valve leaflets 118 towards the closedconfiguration. For example, as retrograde flow begins, the valveleaflets 118 respond by moving towards the center of valve 104. As thevalve leaflets 118 approach the center of the device the valve leaflets118 make sufficient contact to effectively close the reversibly sealableopening 116 of valve 104 and thereby restrict retrograde fluid flow.

In an additional embodiment, the valve leaflets 118 can include one ormore support structures. For example, the valve leaflets 118 can includeone or more support ribs having a predetermined shape. In oneembodiment, the predetermined shape of the support ribs can include acurved bias so as to provide the valve leaflets 118 with a curvedconfiguration. Support ribs can be constructed of a flexible materialand have dimensions (e.g., thickness, width and length) andcross-sectional shape that allows the support ribs to be flexible whenvalve leaflets 118 are urged into an open position, and stiff when thevalve leaflets 118 are urged into a closed position upon experiencingsufficient back flow pressure from the direction downstream from thevalve. In an additional embodiment, support ribs can also be attached tovalve frame 120 so as to impart a spring bias to the valve leaflets ineither the open or the closed configuration.

The valve leaflets 118 can be constructed of a fluid-impermeablebiocompatible material that can be either synthetic or biologic.Possible synthetic materials include, but are not limited to, expandedpolytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE),polystyrene-polyisobutylene-polystyrene, polyurethane, segmentedpoly(carbonate-urethane), Dacron, polyethlylene (PE), polyethyleneterephthalate (PET), silk, urethane, Rayon, Silicone, or the like.Possible biologic materials include, but are not limited to allogeneicor xenograft material. These include explanted veins and decellularizedbasement membrane materials, such as small intestine submucosa (SIS) orumbilical vein.

Valve leaflets 118 can be coupled to the various embodiments of valveframe 120, as described herein, in any number of ways. For example, avariety of fasteners can be used to couple the material of the valveleaflets 118 to the valve frame 120. Fasteners can include, but are notlimited to, biocompatible staples, glues, and sutures. In oneembodiment, the material of the valve leaflets 118 can be wrapped atleast partially around the valve frame 120 and coupled using thefastener. In an additional embodiment, valve leaflets 118 can be coupledto the various embodiments of valve frame 120 through the use of heatsealing, solvent bonding, adhesive bonding, or welding the valveleaflets 118 to either a portion of the valve leaflet 118 (i.e., itself)and/or the valve frame 120. Valve leaflets 118 can also be attached tovalve frame 120 according to the methods described in U.S. PatentApplication Publication 2002/0178570 to Sogard et al., which is herebyincorporated by reference in its entirety.

In an alternative embodiment, the valve 104 can include three leaflets,with the various frames and covering configurations as described herein.Further, valve 104 can be configured to extend proximally and distallyin a curvilinear manner to accommodate the coronary ostia and thediseased valve. For example, leaflets can extend past the coronary ostiain the central portion of the leaflets, and extend to accommodate theattachment points of the diseased valve by incorporating a tri-lobarsaddle shaped configuration. In one embodiment, the valve 104 caninclude a configuration that allows the valve 104 to be placefunctionally distal to the coronary ostia for proper coronary perfusion,while maintaining sufficient clearance for the diseased valve and therepair or replacement of the diseased valve to be performed. Examples ofa three leaflet valve suitable for use as valve 104 are illustrated inU.S. patent application Ser. No. 11/107,162, entitled “Valve Apparatus,System and Method”, and U.S. patent application Ser. No. 10/933,088,entitled “Cardiac Valve, System, and Method”, which is herebyincorporated by reference in its entirety.

In various embodiments, a portion of the elongate filter body 102 caninclude an expandable filter region 150 to filter the unidirectionalflow of the fluid moving through the valve 104. As used herein,filtering of fluid can be accomplished through use of the expandablefilter region 150 by trapping and/or inhibiting the passage ofparticular matter released into and/or present in the fluid movingthrough the valve 104. Trapped particulate matter can then be removedwith the filter system 100 through the lumen 106.

As illustrated in FIGS. 1A-1B, the valve 104 can be adjoined proximalthe distal end 110 of the elongate filter body 102. For example, theframe 120 of the valve 104 can be coupled to the expandable filterregion 150 proximal the distal end 110 of the elongate filter body 102.Methods of coupling the frame 120 to the expandable filter region 150 ofthe elongate filter body 102 can be as described herein for coupling thevalve leaflets 118 to the frame 120.

As will be illustrated herein, the expandable filter region 150 can movebetween a first configuration (e.g., a compressed state, shown in FIG.3A) and a second configuration (e.g., an expanded state, shown in FIGS.1A-1B and FIGS. 2A-2B). In one embodiment, the expandable filter region150 can expand from the first configuration to the second configurationdue to force imparted by the frame 120 as it expands. In addition, theexpandable filter region 150 can expand from the first configuration tothe second configuration by a combination of force imparted by the frame120 as it expands and under pressure of the unidirectional flow of thefluid. Additionally, the force imparted by the frame when the valve isin the open configuration can help to maintain the expandable filterregion expanded when under retrograde fluid flow, such as when the valveis in a closed configuration. In an additional embodiment, theexpandable filter region 150 can be configured to radially self-expandwhen released from a compressed state.

In the various embodiments, the expandable filter region 150 in itsdeployed state can fill the cross-section area of the lumen in which theexpandable filter region 150 and valve 104 are deployed. In addition,filter region 150 in its deployed state can apply sufficient pressure tothe inner wall of the lumen to reduce the volume of fluid (e.g., blood)that may pass between the filter region 150 and the surface of the lumenwall. In one embodiment, the valve frame 120 can be used at least inpart to apply the sufficient pressure to the inner wall of the bodylumen. As will be appreciated, the area and shape defined by theexpandable filter region 150 (e.g., the diameter of the expandablefilter region) in its deployed state can be dependent upon the locationin which the apparatus is intended to be used.

Examples of expandable filter region 150 include those having a woven,braided and/or a knit configuration as the same will be known andunderstood by one of ordinary skill in the art. Alternatively, theexpandable filter regions 150 can be formed of a material having poresformed therein or imparted thereto. In the various embodiments, theexpandable filter regions 150 can be formed of a number of materials.Materials can include polymers, such as ePTFE, PTFE,polystyrene-polyisobutylene-polystyrene, polyurethane, segmentedpoly(carbonate-urethane), Dacron, PE, PET, silk, urethane, Rayon,Silicone, polyamid, mixtures, and block co-polymers thereof.

In one embodiment, expandable filter region 150 can be configured toreduce passage of potentially injurious emboli to arteries feeding thebrain, heart, kidneys, and other tissues and organs. For example,expandable filter region 150 can help to reduce or prevent passage ofemboli greater than about 5 to 1000 micrometers in cross-sectional size.Expandable filter region 150 may also prevent passage of emboli largerthan 50 to 200 micrometers in cross-sectional size. Multiple regions orlayers of expandable filter region 150 may be incorporated to moreefficiently filter emboli, such as a 200 micrometer portion of theexpandable filter region 150 to capture larger particles and a 75micrometer portion of the expandable filter region 150 to capturesmaller particles.

Additional examples of the expandable filter region 150 include theradially self-expanding configurations formed from temperature-sensitivememory alloy which changes shape at a designated temperature ortemperature range. Examples of such materials include, but are notlimited to, nitinol and nitinol-type metal alloys. Alternatively,self-expanding configurations for the expandable filter region 150include those having a spring-bias imparted into the members forming thefilter region 150. The expandable filter region 150 can have a woven,braided and/or a knit configuration that can also impart aself-expanding aspect to the expandable filter region 150.

In an additional embodiment, the filter region 150 can further includeradiopaque markers 152. For example, radiopaque markers (e.g., attachedor coated) can be used to mark the location of the valve 104 and/or theexpandable filter region 150. Other portions of filter system 100 canalso be marked with radiopaque markers as necessary to allow forvisualization of the location and position of parts of the filter system100.

The elongate filter body 102 can further include a fluid tight plug 154positioned within the lumen 106 of the elongate filter body 102. In oneembodiment, the fluid tight plug 154 can be positioned proximal theexpandable filter region 150 so as to occlude the lumen 106, therebydirecting the unidirectional flow of the fluid from the lumen 106through the expandable filter region 150.

The fluid tight plug 154 can have a variety of shapes andconfigurations. For example, a first end 155 and a second end 157 of thefluid tight plug 154 can include a flat planar surface. In analternative embodiment, the first end 155 of the fluid tight plug caninclude a conical configuration, as shown in FIGS. 1A and 1B. Othershapes and configurations for the fluid tight plug 154 are alsopossible.

FIGS. 2A and 2B illustrate an additional embodiment of a filter system200. FIGS. 2A and 2B provide a perspective illustration of the filtersystem 200 that includes both the elongate filter body 202, as describedherein, and the valve 204. In the present example, however, the valve204 includes a frame 220 and a cover 222, including valve leaflets 240and 242 (shown in FIG. 2A), having a different configuration as comparedto the valve 104 described above in FIGS. 1A and 1B. One example ofvalve 204 is illustrated in U.S. patent application Ser. No. 10/741,992,entitled “Venous Valve Apparatus, System, and Method”, which is herebyincorporated by reference in its entirety.

The frame 220 of valve 204 includes an outer surface 256 and an innersurface 258 opposite the outer surface 256. The inner surface 258defines the lumen 212 of the valve 204 for passing fluid therethrough.The frame 220 also includes a first end 262 and a second end 260. In oneembodiment, the cover 222 can be located over at least the outer surface256 of the frame 220. For example, the cover 222 can extend around aperimeter of the frame 220 so as to completely cover the outer surface256 of the frame 220. In other words, the cover 222 extends over theouter surface of the frame 220 so that there are no exposed portions ofthe outer surface 256 of the frame 220. In an additional embodiment, thecover 222 can also be located over at least the inner surface 258 of theframe 220. A further embodiment includes the cover 222 located over atleast the outer surface 256 and the inner surface 258.

In one embodiment, the frame 220 can include an open frame configurationthat includes a first vertex 263 and a second vertex 264 relative thesecond end 260 of the frame 220. Frame 220 can further include a firstvalley 266 and a second valley 268 adjacent the second end 260 relativethe first vertex 263 and the second vertex 264. As illustrated in FIGS.2A and 2B, the first vertex 263 and the second vertex 264 can bepositioned opposite each other along a common axis 270 (shown in FIG.2B). FIGS. 2A and 2B also illustrate that the first valley 266 and thesecond valley 268 can be positioned opposite each other andperpendicular to axis 270. Other relative positions for the first andsecond vertex 263 and 264, and the first and second valley 266 and 268are also possible. As one of ordinary skill will understand, more thantwo vertexes and valleys may be included in the embodiments. Forexample, where an embodiment includes three valve leaflets, e.g., atricuspid valve, three vertexes and three valleys can also be includedto help form the three leaflets.

The cover 222 can further include valve leaflets 240 and 242 that definethe reversibly sealable opening 216 for the unidirectional flow of thefluid through the lumen 212. For example, the surfaces of the cover 222can be deflectable between a closed configuration (FIG. 2B) in whichfluid flow through the lumen 212 can be restricted and an openconfiguration (FIG. 2A) in which fluid flow through the lumen 212 can bepermitted in response to the fluid motion and/or pressure differentialacross the valve leaflets 240 and 242.

The example of valve 204 shown in FIGS. 2A and 2B provide embodiments inwhich the surfaces defining the reversibly sealable opening 216 includethe first leaflet 240 and the second leaflet 242 coupled to the valveframe 220 to provide a two-leaflet configuration (i.e., a bicuspidvalve) for valve 204. Although the embodiments illustrated in FIGS. 2Aand 2B of the present invention show and describe a two-leafletconfiguration for valve 204, designs employing a different number ofvalve leaflets (e.g., tricuspid valve) are also possible.

In one embodiment, each of the valve leaflets 240 and 242 includesufficient excess material spanning valve frame 220 such that fluidpressure (e.g., antegrade flow) acting on the valve leaflets 240 and 242forces the valve 204 into an open configuration (FIG. 2A). Valveleaflets 240 and 242 further include arcuate edges, as illustrated inFIGS. 1A and 1B and shown as 144 and 146, that are positioned adjacenteach other along a substantially catenary curve between the first vertex263 and the second vertex 264 in the closed configuration (Figure B) ofvalve 204. Similarly, arcuate edges 244 and 246 can help to define lumen212 when the valve 204 is in the open configuration (FIG. 2A).

In an additional embodiment, in the open configuration the sufficientexcess material spanning the valve frame 220 between the first vertex263 and the second vertex 264 can allow the valve leaflets 240 and 242to take on a semi-tubular structure, as shown in FIG. 2A, when fluidpressure opens the valve 204. In an additional embodiment, arcuate edge244 and 246 of valve 204 can open to approximately the full innerdiameter of body lumen.

Each of the valve leaflets 240 and 242 can further include a curveimparted thereto so as to provide a concave structure to the leaflet 240and 242. The concave structure allows the valve leaflets 240 and 242 tobetter collect retrograde fluid flow to urge valve leaflets 240 and 242towards the closed configuration (FIG. 2B). For example, as retrogradeflow begins, the valve leaflets 240 and 242 respond by moving towardsthe center of valve 204. As the valve leaflets 240 and 242 approach thecenter of the device the valve leaflets 240 and 242 can make sufficientcontact to effectively close the reversibly sealable opening 116 ofvalve 104 and thereby restrict retrograde fluid flow, i.e., seconddirection 197 as shown in FIGS. 1A and 1B.

FIGS. 3A and 3B provide a further illustration of the filter system 300(i.e., the elongate filter body 302, valve 304, and filter region 350)that includes a sheath 374 having a lumen 376. FIGS. 3A and 3B provide asectional illustration of the filter system 300 at least partiallycontained within a lumen 376 of the sheath 374 (FIG. 3A) and of thefilter system 300 at least partially deployed from the lumen 376 of thesheath 374 (FIG. 3B).

In various embodiments, both the valve 304 and the filter region 350 ofthe elongate filter body 302 can be releasably positioned in a coaxialarrangement within the lumen 376 of the sheath 374. As discussed herein,the configuration of the support frame 320 provides the valve 304 withsufficient flexibility to move between the first configuration 342(e.g., a retracted state within the lumen 376 of the sheath 374 as shownin FIG. 3A) and the second configuration 344 (e.g., an extended stateoutside the lumen 376 of the sheath 374 as shown in FIG. 3B).

In one embodiment, the valve 304 can be configured to reside in thecompressed state when retracted within the lumen 376 of the sheath 374,as illustrated in FIG. 3A, and in an expanded state when extended fromthe lumen 376 of the sheath 374, as illustrated in FIG. 3B. In oneembodiment, the valve 304 expands from its compressed state within thelumen 376 to the deployed state when the sheath 374 is retracted fromaround the valve 304.

The sheath 374 can be formed of a number of materials. Materials includepolymers, such as PVC, PE, POC, PET, polyamid, mixtures, and blockco-polymers thereof. In addition, the sheath 374 can have a wallthickness and an inner diameter sufficient to maintain both the valve304 and the expandable filter region 350 in the retracted state whenthey are positioned within the lumen 376. In an additional embodiment,the sheath 374 can further include radiopaque markers 352. For example,radiopaque markers (e.g., attached or coated) can be used to mark thelocation and allow for visualization of the location and position ofparts of the sheath 374.

In the various embodiments, the support frame 320 of the cardiac valve304 expands to increase the diameter 312 of the lumen 306 of the valve304 as the valve 304 is extended from the sheath 374. In one embodiment,the diameter 312 of the lumen 306 can be determined based upon the typeof body lumen and the body lumen size in which the valve 304 is to beplaced. In an additional example, there can also be a minimum value forthe width for the support frame 320 that ensures that the valve 304 willhave an appropriate expansion force against the inner wall of the bodylumen to prevent retrograde flow within the body lumen.

In addition, the lumen 306 of the elongate filter body 302 in the filterregion 350 also increases in diameter as the valve 304 and the elongatefilter body 302 are extended from the sheath 374. In one embodiment, theexpandable filter region 350 can expand from the first configuration tothe second configuration due in part to force imparted by the frame 320as it expands and under pressure of the unidirectional flow of thefluid. In an additional embodiment, the expandable filter region 350 canbe configured to radially self-expand, as the same has been describedherein, when released from its compressed state within the lumen 376 ofthe sheath 374.

The expandable filter region 350 in its deployed state can fill thecross-section area of a body lumen in which the valve 304 and expandablefilter region 350 are deployed. In addition, filter region 350 in itsdeployed state can apply sufficient pressure to the inner wall of thebody lumen to reduce the volume of fluid (e.g., blood) that may passbetween the filter region 350 and the surface of the body lumen wall. Aswill be appreciated, the area and shape defined by the expandable filterregion 350 (e.g., the diameter of the expandable filter) in its deployedstate will be dependent upon the location in which the filter system isintended to be used.

The filter system 300 can be extended and retracted from the lumen 376of the sheath 374 in any number of ways. For example, the elongatefilter body 302 can be pulled longitudinally within the lumen 376 of thesheath 374 so as to retract the valve 304 and the filter region 350 ofthe elongate filter body 302. In this embodiment, the elongate filterbody 302, supported by the sheath 374, provides sufficient columnstrength to allow force imparted at the proximal end 308 of the elongatefilter body 302 to retract the valve 304 and the filter region 350.

In an additional embodiment, a portion of the elongate filter body 302extending from the filter region 350 to the proximal end 308 can bereinforced and/or have an alternative construction relative the filterregion 350 so as to impart sufficient column strength to the elongatefilter body 302. The elongate filter body 302 can then be pushedlongitudinally within the lumen 376 of the sheath 374 so as to extendthe valve 304 and the filter region 350 of the elongate filter body 302.

In an additional embodiment, the valve 304 and the filter region 350 canbe deployed and retracted by moving the sheath 374 relative the elongatefilter body 302. In this embodiment, the elongate filter body 302 can beheld while the sheath 374 is moved longitudinally so as to either deployor retract the valve 304 and the filter region 350.

The filter system 300 and the sheath 374 can further include handlespositioned at the proximal end 308 of the elongate filter body 302 and afirst sheath end 378 of the sheath 374. In one embodiment, the sheath374 includes a handle 382 and the elongate filter body 302 includes ahandle 384. Handles 382 and 384 allow the sheath 374 and the elongatefilter body 302 to move relative to each other so as to extend and/orretract the valve and a portion of the elongate filter body from thelumen 376 of the sheath 374. In one embodiment, the distance between thehandles 382 and 384 can correspond approximately to the length of thecompacted valve 304 and the filter region 350 to effectively deploy theexpandable filter region 350 and valve 304. Other configurations andrelational lengths are possible.

In an additional embodiment, filter system 300 and the sheath 374 canfurther include a sleeve 386 having a slit 388 and a pull tab 390positioned between the handles during delivery to prevent inadvertentexposure of the valve 304 and filter region 350. For example, the sleeve386 can be stripped from the filter system 300 by pulling the pull tabonce the sheath 374 has been placed at the predetermined location atwhich the valve 304 and the filter region 350 are to be deployed. Otherremovable structures for preventing inadvertent exposure of the valve304 and filter region 350 are also possible.

In an additional embodiment, the filter system 300, as shown in FIG. 3Ccan be extended and/or retracted from the sheath 374 through the use ofa deployment rod 394. In one embodiment, the deployment rod 394 extendsfrom the proximal end 308 of the elongate filter body 302 through thelumen 376 to the fluid tight plug 354, as the same has been described inconnection with FIGS. 1A and 1B. In one embodiment, the deployment rod394 can be used to move the elongate filter body 302 and the valve 304relative the sheath 374.

For example, the deployment rod 394 can extend through the lumen 312 tothe fluid tight plug 354, where the deployment rod 394 can be used topush the filter system 300 relative the sheath 374 to deploy the valve304 and the filter region 350 and/or pull the filter system 300 relativethe sheath 374 to draw the valve 304 and the filter region 350 back intoits compressed state within the lumen 376 of the sheath 374.Alternatively, the deployment rod 394 can be used to change the positionof the valve 304 and filter region 350 once deployed from a firstposition within the lumen to a second position.

In the various embodiments, the deployment rod 394 and the fluid tightplug 354 can further include releasably interconnecting members to allowthe deployment rod 394 and the fluid tight plug 354 to be separated. Forexample, the fluid tight plug 354 can include a socket having threads toreceive and interact with a threaded portion of the deployment rod 394.This structure allows for the deployment rod 394 to be inserted throughthe lumen 376 of the elongate filter body 302 to the fluid tight plug354, where the treaded portion of the deployment rod 394 can be screwedinto the threaded socket of the fluid tight plug 354. The deployment rod394 can then be removed from the lumen 376 by unscrewing the threadedportion of the deployment rod 394 from the threaded socket of the fluidtight plug 354. As will be appreciated, other ways of decoupling thedeployment rod 394 and the fluid tight plug 354 are also possible.

In one embodiment, the deployment rod 394 can be formed of a number ofmaterials. Materials include polymers, such as PVC, PE, POC, PET,polyamid, mixtures, and block co-polymers thereof. In addition, thedeployment rod 394 can be formed of medical grade stainless steel (e.g.,316L), titanium, tantalum, platinum alloys, niobium alloys, cobaltalloys, alginate, or combinations thereof.

FIGS. 4A-4D provides a further illustration of the filter system 400that includes the sheath 474, as previously discussed, and a catheter401 and an apparatus 445. FIGS. 4A-4D provide perspective illustrationsof the filter system 400 at least partially contained within the lumen476 of the sheath 474, with the catheter 401 and the apparatus 445 atleast partially contained within a lumen 406 of the elongate filter body402.

Examples of the catheter 401 and the apparatus 445 are illustrated inU.S. patent application Ser. No. 11/049,000, entitled “VascularCatheter, System, and Method”, which is hereby incorporated by referencein its entirety. In the various embodiments, the catheter 401 includesan elongate body 403 having a first lumen 405 extending between aproximal end 407 and a distal end 409. In one embodiment, the firstlumen 405 allows for additional elongate members to travel along alongitudinal axis of the elongate body 402.

The catheter 401 further includes a first cutting head 411 having ablade 413 and an elongate pulling member 415. The first cutting head 411can be positioned adjacent the distal end 409 of the elongate body 403of the catheter 401 with the elongate pulling member 415 extendingthrough the first lumen 405. In one embodiment, the elongate pullingmember 415 can slide within the first lumen 405 to move the firstcutting head 411 relative the distal end 409 of the elongate body 403 ofthe catheter 401.

The catheter 401 also includes a second cutting head 417 having a blade419. The second cutting head 417 can be positioned adjacent the distalend 409 of the elongate body 403 between the distal end 409 and thefirst cutting head 411. The blade 413 of the first cutting head 411 canmove relative the blade 419 of the second cutting head 417 to provide ashearing action. In one example, the shearing action can be sufficientfor cutting cardiac tissue.

FIG. 4A further illustrates an embodiment in which the second cuttinghead includes an elongate pushing member 421. In one embodiment, theelongate pushing member 421 can slide within the first lumen 405 to movethe second cutting head 417 relative the distal end 409 of the elongatebody 403 and the first cutting head 411. In one embodiment, the elongatepulling member 415 can be arranged concentrically with the elongatepushing member 421 in the first lumen 405.

As illustrated, the elongate pulling member 415, the elongate pushingmember 421 and the first lumen 405 of the elongate body 403 can bepositioned coaxially. In one embodiment, the lumen 405 has a diametersufficient to accommodate the elongate pushing member 421. Similarly,the elongate pushing member 421 had a diameter sufficient to accommodatethe elongate pulling member 415.

In addition, the elongate pulling member 415 and the elongate pushingmember 421 can be structured such that their relative rotationalmovement is restricted. In other words, relative axial rotation of theelongate pulling member 415 and the elongate pushing member 421 isrestricted due to the structure of the members 415 and 421. For example,this can be accomplished using one or more physical structures formed inand/or attached to the members 415 and 421. In one embodiment, one ofthe members 415 or 421 can include a channel through which an extensionfrom the other of the members 415 or 421 can travel so as to inhibitaxial rotation of the members 415 and 421. Alternatively, the members415 and 421 could have a cross-sectional shape that inhibits relativeaxial rotation. Examples of such cross-sectional shapes include oval orelliptical cross-sectional shapes. Other shapes are also possible.

In addition to providing a sufficient diameter, a gap can exist betweenthe opposing surfaces of the first lumen 405 and the elongate pushingmember 421 to allow the elongate pushing member 421 to move through thefirst lumen 405 from force applied at the proximal end of the elongatepushing member 421. Similarly, a gap can exist between the opposingsurfaces of the elongate pushing member 421 and the elongate pullingmember 415 to allow the elongate pushing member 421 and the elongatepulling member 415 to move relative each other from force applied at theproximal end of the elongate pushing member 421 and/or the elongatepulling member 415. The elongate pull member 415 can further include alumen 471 for tracking over a guidewire. A lubricant can be included onthe surfaces of the elongate pulling member 415, the elongate pushingmember 421 and the first lumen 405.

The first cutting head 411 further includes a shape conducive to passingthe catheter 401 and the filter system 400 through a body lumen (e.g., alumen of the cardiovascular system). For example, the first cutting head411 can include a conical shape having a first end 423 and a second end425, where the first end 423 has a diameter that is less than a diameterof the second end 425. Other shapes are also possible. In addition, theshape of the first cutting head 411 can be configured to protectivelyhouse the blade 413 from structures passing by the first end 423 towardsthe second end 425. In other words, the shape of the first cutting head411 can be used to shield the blade 413 from unintentionally interferingand/or cutting tissue within a body lumen.

In one embodiment, the blade 413 can be radially positioned relative theelongate pulling member 415 generally along the second end 425 of thefirst cutting head 411. As will be appreciated, the first cutting head411 can include more than one blade 413. Each blade 413 and 419 furtherincludes a cutting edge 427 and 429, respectively, in alignment so as toprovide shearing action between a pair of the cutting edges 427 and 429of the blades 413 and 419. For example, the first cutting head 411 canmove relative the second cutting head 417 to allow the cutting edge 427of the blade 413 of the first cutting head 411 to slide past the cuttingedge 429 of the blade 417 of the second cutting head 417. Example ofsuitable materials for the blades 413 and 419 include, but are notlimited to, stainless steel (e.g., 316L) and titanium.

In one embodiment, blades 413 and 419 can be secured to the firstcutting head 411 and the second cutting head 417, respectively, in anynumber of ways. For example, blades 413 and 419 can be secured to thecutting heads 411 and 417 through the use of mechanical fasteners, suchas screws, and/or interlocking pins and sockets. In addition, blades 413and 419 can be secured to the cutting heads 411 and 417 through the useof chemical adhesives. Examples of such chemical adhesives include, butare not limited to, medical grade adhesives such as cyanoacrylate,acrylic, silicone, and urethane adhesives.

In an additional embodiment, the first cutting head 411 can beconfigured to receive and house at least a portion of the second cuttinghead 417, including the blade 419, such that the second blade 419 doesnot pass beyond the first cutting head 411. For example, the firstcutting head can include a socket that extends radially relative theelongate pulling member 415 and distally from the blade 413 to receivethe blade 419 of the second cutting head 417 as the blade 419 passes theblade 413. In one embodiment, the blade 419 can be positioned within thesocket of the first cutting head 411 as the catheter 401 is movedthrough a lumen.

Catheter 401 can have various lengths between the proximal end 407 andthe first cutting head 411. In one embodiment, the length between theproximal end 407 and the first cutting head 411 is sufficient to allowthe catheter 401 to be percutaneously implanted through a patient'svasculature to position the cutting heads (e.g., the first and secondcutting heads) at a predetermined location. Examples of thepredetermined locations include, but are not limited to, cardiovascularlocations such as on or adjacent to a cardiac valve of the heart (e.g.,the aortic valve), including within a chamber of the patient's heart(e.g., the left ventricle of the heart). As will be appreciated, thelength between the proximal end 407 and the first cutting head 411 willbe dependent upon each patient's physiological structure and thepredetermined location within the patient.

The elongate body 403 of the catheter 401, the elongate pulling member415, the elongate pushing member 421, the second cutting head 417 andthe first cutting head 411 can be formed from a wide variety ofmaterials and in a wide variety of configurations. For example, thematerials may include, but are not limited to, one or more of polyvinylchloride (PVC), polyethylene (PE), polyolefin copolymer (POC),polyethylene terephthalate (PET), polyamid, mixtures, and blockco-polymers thereof. Alternatively, the materials may include one ormore alloys in any number of configurations. For example, the materialsmay include stainless steel (e.g., 316L), titanium, or other medicalgrade alloys as are known. These materials may also have a wovenconfiguration or a solid extruded configuration.

The selection of material and configuration allows for the elongate body403, the elongate pulling member 415, the elongate pushing member 421,the second cutting head 417 and the first cutting head 411 to each havethe flexibility, and the ability to be either pushed and/or pulledthereby accomplishing the actions described for the components herein.As will be appreciated, selection of the material can be based generallyon a broad range of technical properties, including, but not limited to,modulus of elasticity, flexural modulus, and Shore A hardness requiredfor the embodiments of the present invention. Components of the presentapparatus and/or system can also be coated for lubrication, for abrasionresistance, or to deliver an anticoagulatory drug.

As an alternative configuration, the cutting mechanism of first cuttinghead 411 and second cutting head 417 can be accomplished by alternatecutting, shearing, slicing, grinding or ablative means as are known forother purposes. For example, thermal energy can be used to weaken orslice the diseased valve, rolling cutters could be incorporated, or a“cutting balloon” mechanism could be incorporated.

In an additional embodiment, the catheter 401 can further includeradiopaque markers 431. For example, radiopaque markers (e.g., attachedor coated) can be used to mark the location of the first cutting head411 and the second cutting head 417. In addition, radiopaque markers canbe used to mark the location of blades 413 and 419. Other portions ofcatheter 401 can also be marked with radiopaque markers as necessary toallow for visualization of the location and position of parts of thecatheter 401.

As illustrated in FIG. 4A, catheter 401 can reside at least partiallywithin the lumen 406 of the elongate filter body. FIG. 4B provides anexample in which both the valve 404 and the filter region 450 have beenextended from the sheath 474, as discussed herein, with the catheter 401at least partially extending distally from the valve 404. In the variousembodiments, the valve leaflets of valve 404 can seat around theelongate body 403 of the catheter 401 to provide the reversibly sealableopening of the valve 404.

In the various embodiments, the elongate body 403 can travellongitudinally within the lumen 406 of the elongate filter body 402 toextend and retract the distal end 409 of the catheter 401 relative thevalve 404 of the filter system 400. The elongate filter body 402 canfurther include a sealing ring that allows the elongate body 403 of thecatheter 401 to move longitudinally while maintaining a fluid tight sealwithin the lumen 406 of the elongate filter body 402.

In addition to the structures described herein, the elongate body 403 ofcatheter 401 further includes a second lumen 435, as shown in FIG. 4A.In one embodiment, the second lumen 435 can extend between the proximalend 407 and the distal end 409 of the elongate body 403, where thesecond lumen 435 can be coupled in fluid tight communication to aninflatable balloon 437 on the elongate body 403. The catheter 401 canfurther include an inflation device 495 that can reversibly couple influid tight communication with the second lumen 435 to provide fluidpressure to inflate and deflate balloon 437.

In one embodiment, the inflatable balloon 437 can be positioned adjacentthe distal end 409 of the elongate body 403 and proximal to the secondcutting head 417. The inflatable balloon 437 can be inflated from adeflated state to an inflated state by pressure applied by fluid movingthrough the second lumen 435. In addition, the catheter 401 furtherincludes an expandable stent 439 positioned over at least a portion ofthe inflatable balloon 437. The expandable stent 439 can move between acompressed state, as shown in FIG. 4B, and an expanded state, as shownin FIG. 4C, using the inflatable balloon 437. In one embodiment, theexpandable stent 439 can be deployed over cardiac tissue sheared usingthe first and second cutting heads 411 and 417 using the inflatableballoon 437.

Catheter 401 can further include an annular push ring 441 positionedbetween the second cutting head 417 and the inflatable balloon 437. Theannular push ring 441 can be used for contacting and moving at least aportion of cardiac tissue sheared with the first and second cuttingheads 411 and 417. For example, the first and second cutting heads 411and 417 can be used to shear cardiac tissue (e.g., one or more cusps ofa valve). The annular push ring 441 can then be advanced into contactwith the sheared cardiac tissue. As the annular push ring 441 advancesthe sheared cardiac tissue can be directed towards the wall of thelumen. Stent 439 can then be positioned over at least a portion of thesheared cardiac tissue positioned using the annular push ring 441. Stent439 can then be deployed using the inflatable balloon 437 to position atleast a portion of the sheared cardiac tissue between the expanded stent439 and the wall of the lumen. As will be appreciated, the dimensionsand physical characteristics of the stent 439 will be dependent upon thelocation in which the stent 439 is to be implanted.

The apparatus 445 can further include a cardiac valve 455. The cardiacvalve 455 can be releasably positioned adjacent the expandable stent 439over at least a portion of the inflatable balloon 437. Generally,cardiac valve 455 can be implanted within the fluid passageway of a bodylumen, such as for replacement of a valve structure within the bodylumen to regulate the flow of a bodily fluid through the body lumen in asingle direction.

With respect to the apparatus 445, the cardiac valve 455 can beconfigured to reside in a compressed state over at least a portion ofthe inflatable balloon 437. Using the inflatable balloon, the cardiacvalve 455 can be expanded into a deployed state as illustrated in FIGS.4C and 4D.

One example of cardiac valve 455 includes valve 204 as described herein.An additional embodiment of cardiac valve 455 is illustrated in U.S.patent application Ser. No. 11/049,000, entitled “Vascular Catheter,System, and Method, which is hereby incorporated by reference in itsentirety.

Generally, the cardiac valve 455 includes a support frame and a cover.The cover of the cardiac valve 455 can be positioned over at least theouter surface of the support frame. In one embodiment, the coverincludes surfaces defining a reversibly sealable opening forunidirectional flow of a liquid through the lumen of the cardiac valve455.

The filter system 400, catheter 401 and the apparatus 445 can furtherinclude handles to allow the various components to be moved relativeeach other. For example, handles 479 can allow the elongate pushingmember 421 and/or the elongate pulling member 415 to be moved relativeeach other. Handle 481 can allow the catheter 401 to be moved relativethe apparatus 445 and the sheath 474. In addition, handles 483 can allowthe sheath 474 and the filter system 400 to be moved relative eachother. As will be appreciated, other structures may be used in place ofor in addition to the handles to allow the various components of thefilter system 400, catheter 401, and apparatus 445 to move relative eachother.

The embodiments of the present invention further include methods forforming the filter system and apparatus, as discussed herein. Forexample, embodiments of the present invention can be formed by providingan elongate filter body that includes the expandable filter regiondefining a lumen. The valve can further be provided, where the valve canbe adjoined proximal the distal end of the elongate filter body to forma single lumen through which fluid flows unidirectionally through thevalve and the elongate filter body to filter the fluid. As providedherein, the valve can define a reversibly sealable opening for theunidirectional flow of fluid through the lumen of the valve.

In one embodiment, the expandable filter region can be configured tomove between a first configuration and a second configuration. In oneembodiment, the movement from the first configuration to the secondconfiguration can occur as the valve expands in addition to underpressure of the unidirectional flow of the fluid. The elongate filterbody can also be provided with the fluid tight plug to direct theunidirectional flow of the fluid from the lumen through the expandablefilter region to filter the unidirectional flow of the fluid. In theseembodiments, the fluid tight plug can include various shapes and sizesand can be positioned according to the embodiments described herein.

In various embodiments, the valve can be provided with a support framehaving various configurations. A first configuration can include acompressed configuration and a second configuration can include anexpanded configuration. In various embodiments, expansion of the supportframe can be supplemented by fluid flowing into the lumen of theelongate filter body.

The filter system and apparatus, as discussed herein, can furtherinclude providing the catheter having the first cutting head and thesecond cutting head, as discussed herein. The first cutting head caninclude the blade and the elongate pulling member, where the firstcutting head can be positioned proximal the distal end of the elongatebody with the elongate pulling member extending through the first lumenof the catheter. The elongate pulling member can then slides within thefirst lumen to move the first cutting head relative the distal end ofthe elongate body. The second cutting head can also include a blade, andbe positioned adjacent the distal end of the elongate body between thedistal end and the first cutting head. The blade of the first cuttinghead can be moved relative the blade of the second cutting head toprovide the shearing action for cardiac tissue. The catheter extendsthough the lumen of the elongate filter body and the lumen of the valve.

In additional embodiments, the filter system and apparatus furtherinclude providing a second lumen to the elongate body, where the secondlumen can be in fluid tight communication with the inflatable balloonpositioned adjacent the distal end of the elongate body and proximal tothe second cutting head. The expandable stent can then be positionedover at least a portion of the inflatable balloon, where the inflatableballoon deploys the expandable stent over sheared cardiac tissue. Infurther embodiment, the annular push ring can also be provided betweenthe second cutting head and the inflatable balloon for contacting andmoving at least a portion of the sheared cardiac tissue. The embodimentscan also include providing the cardiac valve positioned over theinflatable balloon, where the cardiac valve can be deployed through theuse of the inflatable balloon.

While the present invention has been shown and described in detailabove, it will be clear to the person skilled in the art that changesand modifications may be made without departing from the spirit andscope of the invention. As such, that which is set forth in theforegoing description and accompanying drawings is offered by way ofillustration only and not as a limitation. The actual scope of theinvention is intended to be defined by the following claims, along withthe full range of equivalents to which such claims are entitled.

In addition, one of ordinary skill in the art will appreciate uponreading and understanding this disclosure that other variations for theinvention described herein can be included within the scope of thepresent invention. For example, the support frame 120 and/or the cover122 can be coated with a non-thrombogenic biocompatible material, as areknown or will be known.

In the foregoing Detailed Description, various features are groupedtogether in several embodiments for the purpose of streamlining thedisclosure. This method of disclosure is not to be interpreted asreflecting an intention that the embodiments of the invention requiremore features than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter lies in less than allfeatures of a single disclosed embodiment. Thus, the following claimsare hereby incorporated into the Detailed Description, with each claimstanding on its own as a separate embodiment.

1. A filter and valve system for use in a body lumen, comprising: anelongate filter body having a tubular shaft including an expandablefilter region fixedly attached at a distal end of the tubular shaftwhich together define a lumen extending from a proximal end of thetubular shaft toward a distal end of the expandable filter region, theexpandable filter region having a collapsed delivery configuration andan expanded configuration; and a balloon catheter comprising a cathetershaft including a first lumen and a second inflation lumen coupled influid tight communication to a distal inflatable balloon on the cathetershaft, wherein the distal inflatable balloon has a first collapsedballoon configuration and a second expanded balloon configuration; aballoon expandable stent mounted on the distal inflatable balloon whenthe distal inflatable balloon is in the first collapsed balloonconfiguration; and a cardiac valve releasably positioned adjacent theballoon expandable stent over at least a portion of the distalinflatable balloon when the distal inflatable balloon is in the firstcollapsed balloon configuration, wherein the balloon catheter, balloonexpandable stent, and cardiac valve are sized and adapted to passthrough the lumen of the tubular shaft and the expandable filter regionwhen the expandable filter region is in the expanded configuration andthe distal inflatable balloon is in the first collapsed balloonconfiguration.
 2. The filter and valve system of claim 1, wherein theballoon catheter, balloon expandable stent, and cardiac valve are sizedand adapted to pass through the lumen of the tubular shaft and theexpandable filter region when the expandable filter region is in thecollapsed delivery configuration and the distal inflatable balloon is inthe first collapsed balloon configuration.
 3. The filter and valvesystem of claim 1, further comprising a sheath defining a lumen whereinthe expandable filter region is at least partially contained within thelumen defined by the sheath when the expandable filter region is in thecollapsed delivery configuration.
 4. The filter and valve system ofclaim 3, wherein the expandable filter region is self-expanding andself-expands upon withdrawal of the sheath relative to the expandablefilter region.
 5. The filter and valve system of claim 3, wherein theexpandable filter region is formed from temperature sensitive memoryalloy which changes shape at a designated temperature.
 6. The filter andvalve system of claim 5, wherein the temperature sensitive memory alloywhich changes shape at a designated temperature is nitinol or anitinol-type alloy.
 7. The filter and valve system of claim 1, whereinthe expandable filter region is formed as a woven, braided, or a knitbody.
 8. The filter and valve system of claim 1, wherein the cardiacvalve includes a support frame and a cover.
 9. The filter and valvesystem of claim 8, wherein the cover is positioned over t least aportion of an outer surface of the support frame.
 10. The filter andvalve system of claim 8, wherein the cover includes surfaces defining areversibly sealable opening for unidirectional flow of a liquid throughthe lumen of the cardiac valve.
 11. The filter and valve system of claim1, wherein cardiac valve is expanded into a deployed state by inflationof the distal inflatable balloon from the first collapsed balloonconfiguration to the second expanded balloon configuration.
 12. Thefilter and valve system of claim 1, wherein the elongate filter bodyfurther includes a fluid tight plug positioned within the lumen definedthereby at the distal end of the tubular shaft.
 13. The filter and valvesystem of claim 1, wherein the elongate filter body further includes avalve defining a valve lumen having a reversibly sealable opening forunidirectional flow of a fluid through the valve lumen.
 14. The filterand valve system of claim 1, wherein the valve is fixedly attached tothe expandable filter region of the elongate filter body.